NCT05320159

Brief Summary

This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,743

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

March 30, 2022

Last Update Submit

June 29, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Treatment satisfaction level at Baseline

    Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

    Baseline

  • Treatment satisfaction level at 6 months post-index

    Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system. For this analysis, the responses were classified into three groups: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

    6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

Secondary Outcomes (12)

  • Age

    Baseline (March 1, 2017 - March 1, 2018)

  • Gender

    Baseline (March 1, 2017 - March 1, 2018)

  • Number of patients at various regions

    Baseline (March 1, 2017 - March 1, 2018)

  • Number of patients with different race

    Baseline (March 1, 2017 - March 1, 2018)

  • Weight

    Baseline (March 1, 2017 - March 1, 2018)

  • +7 more secondary outcomes

Study Arms (5)

Overall cohort: Secukinumab

Included all the patients treated with secukinumab

Drug: Secukinumab

Bio-naive

Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history

Drug: Secukinumab

Bio-experienced

Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history

Drug: Secukinumab

Systemic-naive

Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.

Drug: Secukinumab

Systemic-experienced

Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.

Drug: Secukinumab

Interventions

SecukinumabDRUG

Included all the patients treated with secukinumab

Also known as: Cosentyx
Bio-experiencedBio-naiveOverall cohort: SecukinumabSystemic-experiencedSystemic-naive

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psoriasis patients treated with Cosentyx (secukinumab)

You may qualify if:

  • ≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date
  • Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration
  • ≥18 years of age as of the index date
  • To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation
  • Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period

You may not qualify if:

  • Evidence of secukinumab use in the 12-month pre-index period
  • Data quality issues (missing age, gender, prescription order information)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 11, 2022

Study Start

February 3, 2021

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

US(1)